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Pocket Sized Carotid Stenosis Screening by Junior Doctors

Primary Purpose

Ischemic Attack, Transient, Transient Ischemic Attack, Stroke

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Bed-side pocket size ultrasound imaging
High frame rate tracking doppler
Sponsored by
Helse Nord-Trøndelag HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ischemic Attack, Transient focused on measuring Hand-held, Ultrasound, Diagnosis, Carotid artery stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Admitted to the Department of Medicine with history and findings suspicious of (transient) cerebrovascular ischemia and willing and able to give their informed written consent

Exclusion Criteria:

  • Evaluation of carotid artery stenosis by imaging (CT, MRI or ultrasound) performed during the stay prior to inclusion.

Sites / Locations

  • Department of Medicine, Hospital of Levanger
  • St. Olav University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bed-side pocket-size ultrasound

Arm Description

All participants will be examined bed-side by pocket size ultrasound for the assessment of the carotid arteries by junior doctors. All participants will then be examined by reference imaging in specific ultrasound laboratories with conventional high end equipment and new doppler techniques and when appropriate computer tomography or magnetic resonance imaging.

Outcomes

Primary Outcome Measures

Proportion of patients without need for further diagnostic imaging
Proportion of patients which is not in need of further imaging procedures of the carotid arteries after bed-side diagnostic ultrasound performed by junior doctors with with pocket-sized scanner

Secondary Outcome Measures

Reliability of bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners
The accuracy of semi quantitatively classifications (like i.e. non-significant atherosclerosis of the carotid arteries vs significant stenosis of the carotid arteries) of bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners compared with reference methods performed by experienced personnel
Proportion of interpretable examinations with bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners
Proportion of bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners of sufficient quality compared with reference imaging methods. Quality includes both to what extent the specific structure can be completely assessed, and to what degree the recordings can be interpreted by the operator. Structures and specific functions to be tested: carotid arteries with respect to degree of atherosclerosis and stenosis
Time use of junior doctors performing carotid ultrasound with pocket-sized scanners.
Total time used to record the ultrasound images of the carotid arteries by the junior doctors with pocket-sized ultrasound equipment.
Accuracy of high frame rate tracking doppler compared to conventional doppler measurements and computed tomography for grading carotid stenosis.
Accuracy of velocity measurements with high frame rate tracking doppler for judging degree of stenosis compared to conventional pulsed wave doppler and computed tomography angiography

Full Information

First Posted
December 5, 2016
Last Updated
March 27, 2023
Sponsor
Helse Nord-Trøndelag HF
Collaborators
Norwegian University of Science and Technology, St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02992821
Brief Title
Pocket Sized Carotid Stenosis Screening by Junior Doctors
Official Title
Screening Patients Admitted With Stroke or TIA for Carotid Stenosis by Pocked-Sized Ultrasound in Inexperienced Hands and With Novel Doppler Technology
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Nord-Trøndelag HF
Collaborators
Norwegian University of Science and Technology, St. Olavs Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Among patients admitted with cerebral ischemia (stroke and transitory ischemic attack (TIA)) it is important to reveal the underlying cause of the disease. In special it is important to reveal if carotid artery stenosis is present as such a finding will directly influence on treatment and follow-up. For the diagnosis of carotid artery stenosis due to atherosclerosis ultrasound examinations is the cornerstone, but computer tomography and magnetic resonance imaging may be better in some cases. Development of high quality pocket-sized ultrasound scanners has allowed for semi quantitatively bed-side assessment of the carotid arteries and the heart. The investigators aim to study the feasibility and reliability of bed-side assessment of the carotid arteries by pocket-sized ultrasound scanners in inexperienced hands and the clinical influence of this examination when performed by experienced users. The investigators hypothesize that a significant proportion of this patient population can be clarified bed-side by junior doctors with no need of further imaging procedures for the assessment of the carotid arteries and the heart.
Detailed Description
Population: Approximately 100 patients admitted to the Department of Medicine, Levanger Hospital and Stroke Department, St. Olavs Hospital with history and findings suspicious of stroke/transitory ischemic attack (TIA). Informed consent mandatory. Exclusion criteria: CT angiography of carotid vessels performed after index event, unless all participating clinicians are fully blinded to the results. Hypotheses: The carotid arteries can be assessed bed-side by pocket-size ultrasound scanners with high feasibility and reliability by junior doctors with limited training. Bed-side assessment of the carotid arteries by pocket-size ultrasound scanners may reduce the need for more advanced (higher cost) imaging procedures. New high frame rate tracking doppler can increase accuracy and reproducability of stenosis grading. Methods: Pocket-size imaging device from GE Ultrasound, commercial available. Approved for clinical use. High-end carotid Doppler ultrasound by high-end equipment (GE Vivid 9) and computer tomography and magnetic resonance imaging at the Department of Radiology, Levanger Hospital and St. Olavs Hospital Verasonics research scanner for high fram rate imaging

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Attack, Transient, Transient Ischemic Attack, Stroke, Cerebrovascular Accident, Cerebrovascular Apoplexy
Keywords
Hand-held, Ultrasound, Diagnosis, Carotid artery stenosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bed-side pocket-size ultrasound
Arm Type
Experimental
Arm Description
All participants will be examined bed-side by pocket size ultrasound for the assessment of the carotid arteries by junior doctors. All participants will then be examined by reference imaging in specific ultrasound laboratories with conventional high end equipment and new doppler techniques and when appropriate computer tomography or magnetic resonance imaging.
Intervention Type
Procedure
Intervention Name(s)
Bed-side pocket size ultrasound imaging
Other Intervention Name(s)
GE Ultrasound V-scan Duo probe
Intervention Type
Procedure
Intervention Name(s)
High frame rate tracking doppler
Other Intervention Name(s)
Verasonics research scanner
Primary Outcome Measure Information:
Title
Proportion of patients without need for further diagnostic imaging
Description
Proportion of patients which is not in need of further imaging procedures of the carotid arteries after bed-side diagnostic ultrasound performed by junior doctors with with pocket-sized scanner
Time Frame
The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days
Secondary Outcome Measure Information:
Title
Reliability of bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners
Description
The accuracy of semi quantitatively classifications (like i.e. non-significant atherosclerosis of the carotid arteries vs significant stenosis of the carotid arteries) of bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners compared with reference methods performed by experienced personnel
Time Frame
The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days
Title
Proportion of interpretable examinations with bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners
Description
Proportion of bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners of sufficient quality compared with reference imaging methods. Quality includes both to what extent the specific structure can be completely assessed, and to what degree the recordings can be interpreted by the operator. Structures and specific functions to be tested: carotid arteries with respect to degree of atherosclerosis and stenosis
Time Frame
The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days
Title
Time use of junior doctors performing carotid ultrasound with pocket-sized scanners.
Description
Total time used to record the ultrasound images of the carotid arteries by the junior doctors with pocket-sized ultrasound equipment.
Time Frame
The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days
Title
Accuracy of high frame rate tracking doppler compared to conventional doppler measurements and computed tomography for grading carotid stenosis.
Description
Accuracy of velocity measurements with high frame rate tracking doppler for judging degree of stenosis compared to conventional pulsed wave doppler and computed tomography angiography
Time Frame
The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days
Other Pre-specified Outcome Measures:
Title
Clinical influence of bed-side ultrasound examinations of the carotid arteries in patients admitted with symptoms of stroke
Description
In addition to what described in the primary measure it will be of interest to study predictors of clinical influence of different patient characteristics as age, sex, history, anatomic localization of the vascular event, medication, heart rhythms, ECG findings). Furthermore, the influence on the total cost will be studied.
Time Frame
The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Admitted to the Department of Medicine with history and findings suspicious of (transient) cerebrovascular ischemia and willing and able to give their informed written consent Exclusion Criteria: Evaluation of carotid artery stenosis by imaging (CT, MRI or ultrasound) performed during the stay prior to inclusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Havard Dalen, MD, PhD
Organizational Affiliation
Norwegian University of Science and Tehnology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Hospital of Levanger
City
Levanger
ZIP/Postal Code
7600
Country
Norway
Facility Name
St. Olav University Hospital
City
Trondheim
ZIP/Postal Code
7491
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Depending on university's progress for IPD
Citations:
PubMed Identifier
20702884
Citation
Pepi M, Evangelista A, Nihoyannopoulos P, Flachskampf FA, Athanassopoulos G, Colonna P, Habib G, Ringelstein EB, Sicari R, Zamorano JL, Sitges M, Caso P; European Association of Echocardiography. Recommendations for echocardiography use in the diagnosis and management of cardiac sources of embolism: European Association of Echocardiography (EAE) (a registered branch of the ESC). Eur J Echocardiogr. 2010 Jul;11(6):461-76. doi: 10.1093/ejechocard/jeq045.
Results Reference
background
PubMed Identifier
24788967
Citation
Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1. Erratum In: Stroke. 2015 Feb;46(2):e54.
Results Reference
background
PubMed Identifier
21127304
Citation
Goldstein LB, Bushnell CD, Adams RJ, Appel LJ, Braun LT, Chaturvedi S, Creager MA, Culebras A, Eckel RH, Hart RG, Hinchey JA, Howard VJ, Jauch EC, Levine SR, Meschia JF, Moore WS, Nixon JV, Pearson TA; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Epidemiology and Prevention; Council for High Blood Pressure Research,; Council on Peripheral Vascular Disease, and Interdisciplinary Council on Quality of Care and Outcomes Research. Guidelines for the primary prevention of stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2011 Feb;42(2):517-84. doi: 10.1161/STR.0b013e3181fcb238. Epub 2010 Dec 2. Erratum In: Stroke. 2011 Feb;42(2):e26.
Results Reference
background
PubMed Identifier
22284252
Citation
Mjolstad OC, Dalen H, Graven T, Kleinau JO, Salvesen O, Haugen BO. Routinely adding ultrasound examinations by pocket-sized ultrasound devices improves inpatient diagnostics in a medical department. Eur J Intern Med. 2012 Mar;23(2):185-91. doi: 10.1016/j.ejim.2011.10.009. Epub 2011 Nov 9.
Results Reference
background
PubMed Identifier
21821611
Citation
Skjetne K, Graven T, Haugen BO, Salvesen O, Kleinau JO, Dalen H. Diagnostic influence of cardiovascular screening by pocket-size ultrasound in a cardiac unit. Eur J Echocardiogr. 2011 Oct;12(10):737-43. doi: 10.1093/ejechocard/jer111. Epub 2011 Aug 4.
Results Reference
background
PubMed Identifier
24960705
Citation
Fredriksen TD, Avdal J, Ekroll IK, Dahl T, Lovstakken L, Torp H. Investigations of spectral resolution and angle dependency in a 2-D tracking Doppler method. IEEE Trans Ultrason Ferroelectr Freq Control. 2014 Jul;61(7):1161-70. doi: 10.1109/TUFFC.2014.3015.
Results Reference
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Pocket Sized Carotid Stenosis Screening by Junior Doctors

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